Worksite Wellness Randomized Controlled Trial

NCT02593240 | Completed

• 1 other identifier: 11768
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 1

Brief Summary

Worksites offer attractive locations for reducing the national prevalence of overweight and obesity. Interventions that are both effective and sustainable for producing long-term changes in health and employee wellness are urgently needed. In an 18-month worksite randomized controlled trial in 12 worksites, this study will test two lifestyle approaches designed to facilitate behavior modification for achieving long-term improvements in health and quality of life. Worksites randomized to the immediate intervention arm will receive the two on-site wellness programs and the randomized control sites will participate in outcomes assessments for the initial 6-month period, after which participants will receive vouchers to participate in the program of their choice. The primary focus of the worksite wellness study is to identify ways to improve health-related quality of life, with a particular focus on a decrease in cardiometabolic risk factors, including weight, improved weight-related wellness, and improved energy level in work and life. The two interventions will be separately tested against the control condition in intention-to-treat models and with a completers analysis.

Conditions

Obesity; Overweight; Quality of Life

Keywords

Energy; Presenteeism; Absenteeism; Cardiometabolic health; Obesity; Overweight; Weight Loss; Quality of Life; Weight Control; Eating Behavior; Food Cravings; Hunger; Worksite Wellness

Outcome Measures

Primary Outcomes (2)

• Weight (iDiet/Healthy Weight for Living arms)

  Fasted measurements of weight obtained in duplicate to ±0.1 kg at baseline, 6, 12, and 18 months using the TANITA TBF-300A.

  1.5 years

• Quality of Life (HPI arm)

  Assessed by the RAND Short Form 36 Health Survey (SF-36) at baseline, 6, 12, and 18 months.

  1.5 years

Secondary Outcomes (14)

• Blood pressure

  1.5 years

• Cholesterol

  1.5 years

• Triglycerides

  1.5 years

• Glucose

  1.5 years

• Hemoglobin A1c

  1.5 years

Study Arms (4)

Human Performance Institute©

EXPERIMENTAL

These participants will be part of the intervention sites and will receive the Human Performance Institute© intervention for the duration of the study (18 months).

Behavioral: Human Performance Institute©

The iDiet® with Voucher

EXPERIMENTAL

These participants will be part of the intervention sites and will receive the iDiet® with Voucher for the duration of the study (18 months).

Behavioral: The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Voucher

The iDiet® with Food

EXPERIMENTAL

These participants will be part of the intervention sites and will receive the iDiet® with Food for the duration of the study (18 months).

Behavioral: The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Food

Wait-listed control

NO INTERVENTION

These participants will be part of the control sites and will participate in outcome assessments for a 6-month period only.

Interventions

The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Food BEHAVIORAL

The intensive iDiet® group behavioral weight loss program will be delivered in person at the worksite or by videoconference and with support of the program's web platform. This intervention will be delivered by trained group leaders and will initially include weekly 1-hour support and education meetings of 20 participants/group with a message board for group communication and individual communication with the group leader. Over time support will be provided online rather than in live meetings. The intervention involves a weight loss behavioral program with particular emphasis on hunger reduction and craving control for both weight loss and prevention of weight regain. Half of the participants per worksite receiving the iDiet® intervention will be randomized to receive commercial dried food products (partial supply) from Yevo Intl., which are designed to help with weight control and health.

The iDiet® with Food

The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Voucher BEHAVIORAL

The intensive iDiet® group behavioral weight loss program delivered in person at the worksite or by videoconference and with support of the program's web platform. This intervention will be delivered by trained group leaders and will initially include weekly 1-hour support and education meetings of 20 participants/group with a message board for group communication and individual communication with the group leader. Over time support will be provided online rather than in live meetings. The intervention involves a weight loss behavioral program with particular emphasis on hunger reduction and craving control for both weight loss and prevention of weight regain. Half of the participants per worksite receiving the Diet® intervention will be randomized to receive gift cards monthly for the first 6 months to purchase foods at their local grocery store (partial costs).

The iDiet® with Voucher

Human Performance Institute© BEHAVIORAL

The Human Performance Institute© (HPI) training workshop is a comprehensive individual development training program that focuses on the concept of energy management. The primary aim of this program is to help individuals develop attitudes, habits, and behaviors that increase their levels of daily energy, life satisfaction, and overall functioning. The course is delivered at an off-site location over 2.5 days, by 3 coaches, in a group format of 25 - 32 participants (with employees from more than one worksite per group).

Human Performance Institute©

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to sign an informed consent form
• Willingness to provide release from his/her physician before starting the intervention program-a requirement for each of the 3 wellness programs
• Willingness to provide email identification (ID) and contact information to the commercial program facilitators to receive program materials and other feedback related to program progress
• Willingness to complete outcome assessments and self-monitoring in order to track intervention effectiveness
• BMI ≥ 20 kg/m2 and \< 50 kg/m2 at screening, if participant opts into the HPI arm
• BMI ≥ 25 kg/m2 and \< 50 kg/m2 at screening, if participant opts into the weight loss arm

You may not qualify if:

• Employees who are temporary contract workers or employees who work remotely most of the time
• \< 21 years of age
• Participation in a weight loss program or intensive wellbeing program at time of enrollment
• Pregnant or lactating (per self-reports, now or intended during study)
• Prior weight loss surgery or a medical complication that would prevent full participation
• Multiple severe dietary intolerances (e.g. gluten combined with dairy or meat) which would reduce intervention adherence
• Non-English speaking
• Individuals who have lost \> 15 pounds in the past 6 months
• Mobility limitations (inhibiting the ability to stand on one's own or get on and off of the scale)
• Major diseases including active cancer or cardiovascular disease
• BMI \< 25 kg/m2 or ≥ 50 kg/m2 at screening, for those that opt-in to the weight-loss group
• BMI \<20 kg/m2 or ≥ 50 kg/m2 at screening, for those that opt-in to the HPI group
• Any condition that influences the ability to absorb food (e.g. inflammatory bowel disease or celiac disease)
• Very active individuals (\> 2 hours/day or \>14 hours/week of vigorous activity).

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss; Feeding Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior, Animal; Behavior

Study Officials

• Sai Krupa Das, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

• Susan B Roberts, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: November 2, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

US (1)